Drug updated on 3/28/2024
| Dosage Form | Capsule (oral; 200 mg) |
| Drug Class | Hedgehog pathway inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Summary
- Sonidegib (Odomzo) is used for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
- Two systematic reviews/meta-analyses were reviewed to gather information about Odomzo's efficacy and safety in treating BCC.
- The overall response rate (ORR) for sonidegib was found to be 50.1%, indicating a partial response in most patients receiving this drug as per one study included in the meta-analysis.
- In comparison with another sonic hedgehog inhibitor, vismodegib, sonidegib had lower ORRs both in locally advanced BCC and metastatic disease according to a PRISMA-compliant systematic review followed by a meta-analysis.
- Common adverse effects associated with sonidegib include muscle spasms, dysgeusia, alopecia; additionally more nausea, diarrhea increased creatine kinase levels and decreased appetite compared to those on vismodegib were reported across studies analyzed.
- Despite its effectiveness against advanced BCC disease high discontinuation rates due to side effects have been observed which necessitates careful management of patient expectations when prescribing sonidegib (Odomzo).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Odomzo (sonidegib) Prescribing Information. | 2019 | Sun Pharmaceutical Industries, Inc., Cranbury, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and Safety of Sonic Hedgehog Inhibitors in Basal Cell Carcinomas: An Updated Systematic Review and Meta-analysis (2009-2022) | 2023 | American journal of clinical dermatology |
| Final clinical guidance report: sonidegib (Odomzo). | 2021 | CADTH |
| Efficacy, safety, and comparison of sonic hedgehog inhibitors in basal cell carcinomas: a systematic review and meta-analysis. | 2018 | Journal of the American Academy of Dermatology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Diagnosis and treatment of basal cell carcinoma: European consensus-based interdisciplinary guidelines. | 2019 | European Journal of Cancer |